We deliver a tailored approach to validating your computer systems. Our offer is individually adapted to your initial situation and your needs by
- integrating validation into your quality management system and
- taking into account the regulatory requirements that apply to you (21 CFR Part 11, 820 etc., EU GMP Annex 11, ISO 13485 etc.)
Our risk-based validation approach is aligned with your processes and compliance requirements. We follow the GAMP5® guidelines from ISPE as well as other international best practice approaches.